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Coronary Drug Project

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Clinical trial

The Coronary Drug Project (CDP) was a large clinical trial which assessed several different treatments for coronary heart disease in men with previous myocardial infarction. The study was conducted from 1965 to 1985 at 53 clinical centers and randomized 8,341 men age 30 to 64 years to six different treatment groups: low-dose estrogen therapy (2.5 mg/day oral conjugated estrogens), high-dose estrogen therapy (5 mg/day oral conjugated estrogens), clofibrate (1.8 g/day), dextrothyroxine (6 mg/day), niacin (3 g/day), and placebo (lactose 3.8 mg/day).

The high-dose estrogen group was discontinued in 1970 due to increased non-fatal cardiovascular complications and an unfavorable trend in overall mortality, while the low-dose estrogen group was discontinued in 1970 due to lack of indication of benefit and also an unfavorable trend in overall mortality. Both dose levels of estrogen as well as clofibrate were also found to increase the incidence of gallbladder disease in the study. The dextrothyroxine group was discontinued in late 1971 due to increased cardiovascular mortality.

The Coronary Drug Project Aspirin Study was a substudy of the CDP which randomized men from the estrogen and dextrothyroxine groups of the trial which had been terminated early to either aspirin or placebo.

References

  1. ^ "BioLINCC: Coronary Drug Project (CDP)".
  2. ^ "The Coronary Drug Project. Initial findings leading to modifications of its research protocol". JAMA. 214 (7): 1303–13. November 1970. doi:10.1001/jama.1970.03180070069012. PMID 4320008.
  3. ^ "The Coronary Drug Project: Design, Methods, and Baseline Results". Circulation. 47 (3 Suppl): I1–50. March 1973. doi:10.1161/01.cir.47.3s1.i-1. PMID 4570454. S2CID 22194468.
  4. "The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. The coronary Drug Project Research Group". JAMA. 226 (6): 652–7. November 1973. doi:10.1001/jama.1973.03230060030009. PMID 4356847.
  5. ^ Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W (December 1986). "Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin". J Am Coll Cardiol. 8 (6): 1245–55. doi:10.1016/s0735-1097(86)80293-5. PMID 3782631.
  6. Stamler J (1977). "The Coronary Drug Project --- Findings with Regard to Estrogen, Dextrothyroxine, Clofibrate and Niacin". Atherosclerosis. Advances in Experimental Medicine and Biology. Vol. 82. pp. 52–75. doi:10.1007/978-1-4613-4220-5_6. ISBN 978-1-4613-4222-9. PMID 335823.
  7. Coronary Drug Project Research Group (May 1977). "Gallbladder disease as a side effect of drugs influencing lipid metabolism. Experience in the Coronary Drug Project". N Engl J Med. 296 (21): 1185–90. doi:10.1056/NEJM197705262962101. PMID 323705.
  8. "The coronary drug project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. The coronary drug project research group". JAMA. 220 (7): 996–1008. May 1972. doi:10.1001/jama.1972.03200070084015. PMID 4337170.
  9. "The coronary drug project aspirin study. Implications for clinical care. Coronary Drug Project Research Group". Prim Care. 5 (1): 91–5. March 1978. doi:10.1016/S0095-4543(21)00774-0. PMID 349581.
  10. "Aspirin in coronary heart disease. The Coronary Drug Project Research Group". Circulation. 62 (6 Pt 2): V59–62. December 1980. PMID 7002353.
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